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- Define the reference period and/or reference time point(s) in the context of the study.
- Collect the start and end date/times of the reference period and/or the date/time of the reference time point(s) using appropriate TIG collection or CDASH Model fields.
- Collect the actual timing of observations when it is possible to collect the date(s) for a related observation.
- Collect relative timing of observations when collection of actual dates is not possible using fields --PRIOR and --ONGO (e.g., “prior”, “ongoing”) for when an observation started or continued, in relation to the study reference period and/or reference time point(s).
The figures below show examples of collection of relative timing in relation to a reference period and reference time points; the table that follows describes the figures. Representation of collected reference dates and relative timing in subsequent tabulation datasets is noted below and further described in Section 2.7.4.1,
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